- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03674866
A Canadian Study of the Effectiveness of Tresiba® (Insulin Degludec) After Switching Basal Insulin in a Population With Type 1 or Type 2 Diabetes Mellitus (CAN-TREAT)
December 5, 2019 updated by: Novo Nordisk A/S
A Canadian Multi-centre, Retrospective, Non-interventional Study of the Effectiveness of Tresiba® (Insulin Degludec) After Switching Basal Insulin in a Population With Type 1 or Type 2 Diabetes Mellitus CAN-TREAT (CANadian TREsiba AudiT)
The purpose of this study is to collect historical data in real life conditions in a large group of people who have type 1 or type 2 diabetes and were treated with Tresiba® (insulin degludec) for at least 6 months.
Data will be collected beginning 6 months before the participant started Tresiba® up to around 6 months after the participant started taking insulin degludec.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
662
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2H 2G4
- Novo Nordisk Investigational Site
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Edmonton, Alberta, Canada, T5T 3J7
- Novo Nordisk Investigational Site
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British Columbia
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Vancouver, British Columbia, Canada, V6J 4Y3
- Novo Nordisk Investigational Site
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
- Novo Nordisk Investigational Site
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Shubenacadie, Nova Scotia, Canada, B2T 1A4
- Novo Nordisk Investigational Site
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Sydney, Nova Scotia, Canada, B1P 1P3
- Novo Nordisk Investigational Site
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Ontario
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Ajax, Ontario, Canada, L1Z 0M1
- Novo Nordisk Investigational Site
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Brampton, Ontario, Canada, L6S 0C6
- Novo Nordisk Investigational Site
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Cambridge, Ontario, Canada, N1R 7L6
- Novo Nordisk Investigational Site
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Concord, Ontario, Canada, L4K 4M2
- Novo Nordisk Investigational Site
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Etobicoke, Ontario, Canada, M9R 4E1
- Novo Nordisk Investigational Site
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Guelph, Ontario, Canada, N1H 3R3
- Novo Nordisk Investigational Site
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London, Ontario, Canada, N6G 2M1
- Novo Nordisk Investigational Site
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London, Ontario, Canada, N6A 4V2
- Novo Nordisk Investigational Site
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Markham, Ontario, Canada, L3P 7P2
- Novo Nordisk Investigational Site
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Markham, Ontario, Canada, L3S 0A2
- Novo Nordisk Investigational Site
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Nepean, Ontario, Canada, K2J 0V2
- Novo Nordisk Investigational Site
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Oakville, Ontario, Canada, L6M 1M1
- Novo Nordisk Investigational Site
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Orillia, Ontario, Canada, L3V 2Z6
- Novo Nordisk Investigational Site
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Scarborough, Ontario, Canada, M1E 5E9
- Novo Nordisk Investigational Site
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Smiths Falls, Ontario, Canada, K7A 4W8
- Novo Nordisk Investigational Site
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Tecumseh, Ontario, Canada, N8N 4M7
- Novo Nordisk Investigational Site
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Toronto, Ontario, Canada, M6G 1M2
- Novo Nordisk Investigational Site
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Toronto, Ontario, Canada, M4G 3E8
- Novo Nordisk Investigational Site
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Quebec
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Gatineau, Quebec, Canada, J8Y 0A7
- Novo Nordisk Investigational Site
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Laval, Quebec, Canada, H7T 2P5
- Novo Nordisk Investigational Site
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Montreal, Quebec, Canada, H4T 1Z9
- Novo Nordisk Investigational Site
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Montreal, Quebec, Canada, H4A 2C6
- Novo Nordisk Investigational Site
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Montreal, Quebec, Canada, H4A 3T2
- Novo Nordisk Investigational Site
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Montreal, Quebec, Canada, H2K 1H2
- Novo Nordisk Investigational Site
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Pierrefonds, Quebec, Canada, H8Z 1W5
- Novo Nordisk Investigational Site
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Terrebonne, Quebec, Canada, J6X 4P7
- Novo Nordisk Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with type 1 or type 2 diabetes mellitus whose basal insulin was switched to insulin degludec
Description
Inclusion Criteria:
- Informed consent will be obtained before any study-related activities. Study-related activities are any data collection from the medical records of the patient
- Male or female age greater than or equal to 18 years at the time of insulin degludec initiation
- Type 1 diabetes mellitus or insulin-treated type 2 diabetes mellitus patients
- Switched to insulin degludec (± prandial insulin) after any basal insulin (± prandial insulin). Switch must have occurred at least 6 months prior to data collection and the patient may or may not be treated with insulin degludec at the time of patient selection
- Previously treated with any basal insulin (± prandial insulin) for at least 6 months prior to switching to insulin degludec
- At least one documented medical visit in the first 6 months (closest value in 3 to 9 months window) after insulin degludec initiation
- Minimum available data at the time of insulin degludec initiation: age, type of diabetes, HbA1c, duration of diabetes, duration and type of insulin treatment, medical follow-up at the study site for at least 1 year, and an estimated glomerular filtration rate (eGFR) value in the last 12 ±6 months (full data period)
Exclusion Criteria:
- Previous participation in this study. Participation is defined as having signed the Informed Consent in this study
- Patients treated by continuous subcutaneous insulin infusion or premix insulin in the 6 months prior to receiving Tresiba
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with diabetes
Patients with type 1 diabetes and type 2 diabetes who received at least one prescription of insulin degludec (Tresiba®).
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Participants are treated with Tresiba® (insulin degludec) under conditions of routine care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Glycated Haemoglobin (HbA1c)
Time Frame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
|
measured in % point
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Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in percentage of patients with HbA1c below 7%
Time Frame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
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percentage of patients
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Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
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Change in percentage of patients with HbA1c below 7.5%
Time Frame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
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percentage of patients
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Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
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Change in percentage of patients with HbA1c below 8.0%
Time Frame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
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percentage of patients
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Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
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Change in the mean Fasting Plasma Glucose (FPG)
Time Frame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
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measured in mmol/L
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Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
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Insulin degludec dose
Time Frame: At switch to insulin degludec (week 0)
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measured in units/day
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At switch to insulin degludec (week 0)
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Insulin degludec dose
Time Frame: 6 months after switch to insulin degludec
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measured in units/day
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6 months after switch to insulin degludec
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Change in the mean daily insulin doses (total, basal, prandial)
Time Frame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
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measured in units/day
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Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
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Change in the number of concomitant non-insulin glucose-lowering drug classes
Time Frame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
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number of concomitant non-insulin glucose-lowering drug classes
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Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
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Change in body weight
Time Frame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
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measured in kg
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Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
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Change in the percentage of patients with at least one hypoglycaemic episode (overall, nonsevere,non-severe)
Time Frame: Before change to insulin degludec (-6 to 0 months)
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percentage of patients
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Before change to insulin degludec (-6 to 0 months)
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Change in the percentage of patients with at least one hypoglycaemic episode (overall, nonsevere,non-severe)
Time Frame: After change to insulin degludec (0 to 6 months)
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percentage of patients
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After change to insulin degludec (0 to 6 months)
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Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal)
Time Frame: Before change to insulin degludec (-6 to 0 months)
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rates of hypoglycaemic episodes
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Before change to insulin degludec (-6 to 0 months)
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Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal)
Time Frame: After change to insulin degludec (0 to 6 months)
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rates of hypoglycaemic episodes
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After change to insulin degludec (0 to 6 months)
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Percentage of patients continuing insulin degludec
Time Frame: After change to insulin degludec (0 to 6 months)
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percentage of patients
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After change to insulin degludec (0 to 6 months)
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Reason(s) for starting insulin degludec
Time Frame: At time of switch to insulin degludec (week 0)
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Reasons for starting insulin degludec (if available) will be classified as: Not at glycaemic target, Hypoglycaemia (severe / non-severe / nocturnal), Hypoglycaemia unawareness, Multiple risk factors for hypoglycaemia (elderly, intensive exercise, Chronic Kidney Disease, other), Basal insulin dose more than 80 units/day, Twice daily basal insulin dosing, Fasting blood glucose variability, Need for flexible time of dosing, Device issue, other
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At time of switch to insulin degludec (week 0)
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Reason(s) for discontinuing insulin degludec
Time Frame: At time of discontinuing insulin degludec (0 to 6 months)
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Reasons for discontinuing insulin degludec (if applicable and available) will be classified as: Injection site reaction, Insufficient efficacy, Hypoglycaemia (severe / non-severe / nocturnal), Weight gain, Cost, Device issue, Other
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At time of discontinuing insulin degludec (0 to 6 months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 29, 2018
Primary Completion (Actual)
April 25, 2019
Study Completion (Actual)
April 26, 2019
Study Registration Dates
First Submitted
September 5, 2018
First Submitted That Met QC Criteria
September 14, 2018
First Posted (Actual)
September 18, 2018
Study Record Updates
Last Update Posted (Actual)
December 6, 2019
Last Update Submitted That Met QC Criteria
December 5, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN1250-4396
- U1111-1203-7872 (Other Identifier: World Health Organization (WHO))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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